Device Classification Name |
pump, infusion
|
510(k) Number |
K993524 |
Device Name |
ADVANTIS ASC INFUSION PUMP AND ADMINISTRATION SETS |
Applicant |
ALARIS MEDICAL SYSTEMS, INC. |
10221 WATERIDGE CIR. |
SAN DIEGO,
CA
92121
|
|
Applicant Contact |
RENEE L FLUET |
Correspondent |
ALARIS MEDICAL SYSTEMS, INC. |
10221 WATERIDGE CIR. |
SAN DIEGO,
CA
92121
|
|
Correspondent Contact |
RENEE L FLUET |
Regulation Number | 880.5725
|
Classification Product Code |
|
Date Received | 10/18/1999 |
Decision Date | 08/01/2000 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General Hospital
|
510k Review Panel |
General Hospital
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|